YES!!! It is here. Phase II vaccine trial for Her2 3+
Galena Biopharma, Inc.
Nov 11, 2014 Previous Release PDF Add to Briefcase Galena Biopharma Doses First Patient in Phase 2 Clinical Trial With NeuVax(TM) (nelipepimut-S) in Combination With Herceptin(R) (trastuzumab) to Treat High-Risk HER2 3+ or HER2 Gene-Amplified Breast Cancer Patients Trial expands the eligible patient population and overall NeuVax clinical trial portfolio Recent patent allowance provides intellectual property protection for NeuVax in combination with Herceptin in any HER2/neu expressing cancer PORTLAND, Ore., Nov. 11, 2014 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major medical needs across the full spectrum of cancer care, today announced the dosing of the first patient in a new NeuVax™ (nelipepimut-S) Phase 2 clinical trial to prevent breast cancer recurrence in high risk HER2 3+ and/or HER2 gene-amplified breast cancer patients in combination with Herceptin® (trastuzumab; Genentech/Roche). The patients will be defined as 3+ by immunohistochemistry (IHC) or are HER2 2+ and/or fluorescence in situ hybridization (FISH) > 2.0, also described as gene-amplified. The multi-center, prospective, randomized, single-blinded, placebo-controlled, Phase 2 trial will enroll 100 patients with a diagnosis of HER2 3+ or gene-amplified breast cancer, are HLA A2+ or HLA A3+, and are determined to be at high-risk for recurrence. "This trial is a significant addition to our portfolio of NeuVax clinical trials that are exploring the potential of the agent to prevent recurrence in a variety of cancer settings," said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. "Herceptin has shown efficacy in HER2 3+ patients; however, those patients who fall into the high risk category are at much greater risk for a recurrence following standard of care treatment. Based on early studies and pre-clinical data, the combination of NeuVax and Herceptin has shown that the two agents utilize different mechanisms of action to target the same protein, leading to a potentially strong synergistic effect that may provide clinical benefit in this high-risk population. We are excited for the potential to help these high risk patients." This trial is co-funded via a grant from the Department of Defense through the Congressionally Directed Medical Research Program. The grant comes via a Breast Cancer Research Program Breakthrough Award and was obtained by Elizabeth A. Mittendorf, M.D., Ph.D., Associate Professor, Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, who will oversee this investigator-initiated trial. "The women we are treating in this trial are at a high risk for their disease to recur, particularly because their initial treatment regimen failed to give them a complete response. I believe that NeuVax and Herceptin are complementary to one another and the combination of these agents may provide clinical benefit to these patients," added Dr. Mittendorf. Eligible breast cancer patients will be randomized to receive NeuVax + GM-CSF (granulocyte macrophage-colony stimulating factor) + trastuzumab or trastuzumab + GM-CSF alone in the adjuvant setting following surgery. The primary endpoint of the study is invasive disease-free survival and enrollment is expected to complete in the second half of 2016, followed by a 3-year follow-up period. There are three categories of high-risk patients that qualify for the trial: Patients who received neoadjuvant therapy (before surgery) with an approved regimen that includes trastuzumab and at least four cycles (12 weeks) of taxane-containing chemotherapy but fail to obtain a pathological complete response (pCR) at surgery, regardless of hormone receptor status. Patients who undergo surgery as a first intervention and are found to be pathologically node-positive with at least four positive lymph nodes, regardless of hormone receptor status. Hormone receptor negative breast cancer patients who undergo surgery as a first intervention and are found to have one, two or three positive lymph nodes. On October 8, 2014, Galena announced the Notice of Allowance of a U.S. patent application covering methods of treating patients having any HER2/neu expressing cancer by administering NeuVax™ (nelipepimut-S) in combination with Herceptin® (trastuzumab; Genentech/Roche). About NeuVax™ (nelipepimut-S) NeuVax™ (nelipepimut-S) is the immunodominant peptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut-S sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs) following binding to HLA-A2/A3 molecules on antigen presenting cells (APCs). These activated, specific CTLs recognize, neutralize and destroy, through cell lysis, HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut-S immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading. NeuVax is currently in an international, Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVaxTreatment) study under a Special Protocol Assessment (SPA) granted by the U.S. Food and Drug Administration (FDA). Additional information on the PRESENT trial can be found at www.neuvax.com. Two additional Phase 2 trials are ongoing with NeuVax in combination with Herceptin® (trastuzumab; Genentech/Roche). About HER2 3+ Breast Cancer According to the National Cancer Institute, over 230,000 women in the U.S. are diagnosed with breast cancer annually. Of these women, about 25% are HER2 positive (IHC 3+), which means their breast cancer cells significantly over express the HER2 protein. HER2 is a member of the epidermal growth factor receptor family of receptor tyrosine kinases. Increasing levels of HER2 expression have been shown to be a prognostic indicator for poor outcomes in breast cancer. Patients with HER2 3+ tumors, or HER2 2+ and/or FISH > 2.0 tumors (gene-amplified) may receive trastuzumab, a humanized mAb targeting HER2, as a component of their standard of care therapy. In HER2 3+ breast cancer patients who receive neoadjuvant chemotherapy plus trastuzumab, the 3-year estimate of recurrence free survival are 95.7% for patients that achieve a pCR versus 80.1% for patients that do not achieve a pCR (p=.02). For HER2 3+ or gene-amplified breast cancer patients that undergo surgery as a first intervention and are found to be node-positive, 5-year disease free survival rates are 72% for those with four or more positive lymph nodes and 78% for those with 1, 2 or 3 positive lymph nodes. About Galena Biopharma Galena Biopharma, Inc. (Nasdaq:GALE) is a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care. Galena's development portfolio ranges from mid- to late-stage clinical assets, including a robust immunotherapy program led by NeuVax™ (nelipepimut-S) currently in an international, Phase 3 clinical trial. The Company's commercial drugs include Abstral® (fentanyl) Sublingual Tablets and Zuplenz® (ondansetron) Oral Soluble Film. Collectively, Galena's clinical and commercial strategy focuses on identifying and advancing therapeutic opportunities to improve cancer care, from direct treatment of the disease to the reduction of its debilitating side-effects. For more information, visit www.galenabiopharma.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the expected timing of completion of enrollment and the completion of the NeuVax combination HER2 3+ breast cancer clinical trial, the design of the clinical trial and the importance of the results from such trial, if reported to the medical community, the commercialization of Galena's products and development of Galena's product candidates, as well as statements about our expectations, plans and prospects. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those identified under "Risk Factors" in Galena's Annual Report on Form 10-K for the year ended December 31, 2013 and most recent Quarterly Reports on Form 10-Q filed with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. Galena does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this press release. NeuVax™ is a trademark of Galena Biopharma, Inc. Other trademarks are the property of their respective owners. CONTACT: Remy Bernarda VP, Marketing & Communications (503) 405-8258 rbernarda@galenabiopharma.com |
Re: YES!!! It is here. Phase II vaccine trial for Her2 3+
YAAYYYY...thanks for posting Mister Sister...hope all is well in your world!! :)
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Re: YES!!! It is here. Phase II vaccine trial for Her2 3+
I am doing great Mister Sister. Life justs gets better and better.
I was just thinking about you this week. How is life for you? |
Re: YES!!! It is here. Phase II vaccine trial for Her2 3+
That is wonderful to hear...actually...having problems with hypothyroid...TSH was 0.12... blood drawn per PA was 6 mo, then 3 mo...now being referred to an endo...who nows what the next step will be...and throw in a rash, inflammation, ititching on my mastectomy side...had an utrasound, was told it's JUST tissue...so tired of having such thin skin and ending up with nearly just bone from immediate infection after failed reconstruction...going to have a visit with my PS this Friday...LIFE COULD BE SO MUCH WORSE THOUGH...I sure am concerned about Linn...??
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Re: YES!!! It is here. Phase II vaccine trial for Her2 3+
I will message you.
I am worried about Linn too. I don't like the radio silence. Let's message her too. So much progress being made for us, first Prop 303 passes in AZ, and now the Phase II for Neuvax. I AM SO HAPPY! We should help find 99 more to enroll so that the Phase II finishes quickly. So important to get this done so less have to deal with the agony of progression. |
Re: YES!!! It is here. Phase II vaccine trial for Her2 3+
Good point, Susan - Linn has been very quiet. Concerned, too
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Re: YES!!! It is here. Phase II vaccine trial for Her2 3+
Indeed...great progress being made...will "stay tuned" to hear from you...miss you!! :(
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Re: YES!!! It is here. Phase II vaccine trial for Her2 3+
It is a pity that it is only for HLA A2 positive or A3 positive ladies. Alas I am none of these, so despite being Her3+ I am ineligible. I also have some stuff to clear out of my lungs first :) I will pass this on to anyone I know who is HLA A2 positive.
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Re: YES!!! It is here. Phase II vaccine trial for Her2 3+
Ouch Waterdreamer, don't be so discriminatory. Surely they will let men into the trial too. After all they specify patients, not just ladies. :) Plus I just told James that perhaps he could make it into the trial.
I've been hoping for cancer treatments based on our own individual cancer characteristics. It is a blessing that a vaccine is in Phase II & Phase III for both HLA A2 or HLA A3 positive. It is my impression this is a fairly large group. It is a pity that the AE37 vaccine which includes the HLA A2 negatives in only in Phase IIb for lower expressors. It is my impression that taking this vaccine into Phase III is delayed until the funding is available. Perhaps when that happens they will once again include the Her2 3+ as well. |
Re: YES!!! It is here. Phase II vaccine trial for Her2 3+
Ooops, sorry didn't mean to ignore the men amongst us. I just get tired of being called a patient, it feels as if some control has been taken away, so let me rephrase -
It is a pity that it is only for HLA A2 positive or A3 positive ladies and gentlemen. :) |
Re: YES!!! It is here. Phase II vaccine trial for Her2 3+
Hope this one will be effective for those who can get it.
There was a vaccine here at the U of W Tumor Group that was only for those with HLA A2. I took a specific blood test for that and was negative, so that vaccine was out for me. I know there were others on this board who also had their HLA tested and were also knocked out as they did not come up as HLA A2. I know I was not HLA A3 either. The vaccine I did get did not hinge on any HLA testing or specific number. |
Re: YES!!! It is here. Phase II vaccine trial for Her2 3+
I'm still looking for a vaccine trial that will also address those of us who are currently cancer free (scared to use the NED word).
The Neuvax Phase II is only for those with active cancer (if I'm reading it correctly). |
Re: YES!!! It is here. Phase II vaccine trial for Her2 3+
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Waterdreamer, that is better, funny. I will call you an "Impatient" because you are tired of dealing with cancer. I am HLA A2 positive, so am quite happy about Neuvax :) |
Re: YES!!! It is here. Phase II vaccine trial for Her2 3+
Jaykay, I'm with you. I wish I could join this vaccine trial. Because I had pathological complete response after responding to neoadjuvant treatment, I don't qualify.
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Re: YES!!! It is here. Phase II vaccine trial for Her2 3+
Thinkpositive, keep working on the positive . . .
We should start another thread about pCR after neoadjuvant treatment and share the latest numbers. Perhaps the data is not out too many years in a large number of patients, but my expectation is that recurrence rates in this subset is extremely rare. I understand about wanting to throw every treatment option at cancer (but the kitchen sink). There is the law of diminishing returns, and (like flying) the backside of the power curve, where the more you give (such as cancer treatments) the worse the situation becomes. There comes a time to accept good fortune, such as a complete response, and acknowledge the blessing of being one of the lucky ones with a great prognosis. I personally am ready for vaccines to be approved. I've watched many women suffer through the trauma over a recurrence in the last 7 years since I've been diagnosed. And I've been with those who remained cancer free but suffered through the worry and anxiety about recurrence for years. I was disappointed about the PRESENT trial only being for low expressors. Yet, I was excited for the ladies (and gentlemen) who got lumped into triple negative standard of care and were excluded from Her2 treatments. With interim data, 1 of 4 progressed within the control arm, and for 48 months no one progressed in the vaccine arm. I believe we should be very excited when a subset is successfully treated, such as HLA A2 positive. We should be very excited when treatments cross over from breast cancer - to gastric cancer - to prostate cancer. What wonderful progress! And by dividing and conquering, more and more researchers can focus on helping the subsets of us that need better treatments. So if you are HLA A2 negative, it is not necessarily a treatment option that should be for the negatives, but find another positive marker that another subset has in common. Focus on treating that. Another good reason to "Think Positive" . . . |
Re: YES!!! It is here. Phase II vaccine trial for Her2 3+
Don't get me wrong, I think it's great that they are expanding the phase 2 trial, but as think said, i don't fall into any of those categories and neither does she. Hope we don't have to wait too long...
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Re: YES!!! It is here. Phase II vaccine trial for Her2 3+
Oh . . . you mean that you two instantly "rained on my parade"?
I had forgotten about the HLA status. What does that mean anyway? So here is what I found on Wiki and I will be keeping an eye out for more information. Quote:
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Re: YES!!! It is here. Phase II vaccine trial for Her2 3+
More information from Wiki on HLA
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Re: YES!!! It is here. Phase II vaccine trial for Her2 3+
This article from a couple years ago might explain it better:
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Re: YES!!! It is here. Phase II vaccine trial for Her2 3+
Oh, so here is the one for you JayKay, and I quote:
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Re: YES!!! It is here. Phase II vaccine trial for Her2 3+
Lizbeth,
Thanks for your post. You are absolutely right. I'm very grateful to have achieved a pathological complete response. I should just focus more on that rather than on not being eligible for the trial. I appreciate the reminder. Having the trial opened to other HER2 folks is huge! Take care |
Re: YES!!! It is here. Phase II vaccine trial for Her2 3+
I know there is more information out there about the pCR- as we on the board have discussed it. Still looking, but I think the prognosis is very very good.
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Re: YES!!! It is here. Phase II vaccine trial for Her2 3+
Hi I hope you are well. I am in Minnesota. I was in a clinical trial in 2011. so far so good. But it has been a long a painful journey. Lots of surgery and depression, stuff like that.
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Re: YES!!! It is here. Phase II vaccine trial for Her2 3+
Sandra,
My best advice is exercise. Not only is the benefit from aerobic levels shown to reduce recurrence of cancer, but it also helps with depression. Force yourself to get out and try walking, jogging, hiking, bicycling, running, aerobics class, swimming or anything else that gets the heart rate up between 45% - 60% of your maximum heart rate. You can google studies on METs (a measurement of breath). I feel for you on the depression. Start looking for little things that give you pleasure: music, art, dance, writing, socializing, movies. Medications can help, but fight depression on all fronts is how I feel. Good luck |
Re: YES!!! It is here. Phase II vaccine trial for Her2 3+
Oh, and don't do an extreme amount of exercise if you've been sedentary. Build up. Check with your doctor if your heart was affected by treatment, then be more cautious.
Be aware of recovery heart rates. The heart should be in recovery mode about a minute after exercise and the heart rate will start returning to the resting rate. Any questions ask your doctor. |
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